Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:02 PM
Ignite Modification Date:
2025-12-24 @ 1:02 PM
NCT ID:
NCT00016861
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed solid tumor refractory to standard therapy or for which no known effective therapy exists
* Brain tumors eligible
* Histologic verification waived for brain stem gliomas
* Evaluable disease
* No bone marrow involvement
PATIENT CHARACTERISTICS:
Age:
* 1 to 21
Performance status:
* Karnofsky 50-100% (over age 10)
* Lansky 50-100% (age 10 and under)
Life expectancy:
* At least 8 weeks
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 8 g/dL
Hepatic:
* Bilirubin less than 1.5 mg/dL
* SGPT less than 5 times normal
Renal:
* Creatinine normal OR
* Glomerular filtration rate at least 70 mL/min
Other:
* No uncontrolled infection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 6 months since prior autologous bone marrow transplantation (BMT) (not including stem cell rescue after high-dose chemotherapy)
* At least 1 week since prior growth factors
* No prior BMT with total body irradiation (stratum I)
* No prior BMT with or without total body irradiation (stratum 2)
* No prior allogeneic BMT (all strata)
* No concurrent sargramostim (GM-CSF)
* No other concurrent prophylactic growth factor support during the first course of therapy
Chemotherapy:
* At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas)
* No prior irinotecan
* No more than 2 prior multi-agent chemotherapy regimens (stratum 2)
* No other concurrent chemotherapy
Endocrine therapy:
* Concurrent dexamethasone allowed if on stable or decreasing dose for at least 2 weeks prior to study
Radiotherapy:
* At least 6 months since prior craniospinal radiotherapy or radiotherapy to 50% or more of the pelvis
* At least 6 weeks since other prior substantial bone marrow radiotherapy
* No prior central axis radiotherapy, pelvic radiotherapy, and/or total abdominal radiotherapy (stratum 2)
Surgery:
* Not specified
Other:
* Recovered from all prior therapy
* No other concurrent investigational agents
* Concurrent enzyme-inducing anticonvulsants (e.g., phenytoin, phenobarbital, carbamazepine) allowed if on stable dose for at least 2 weeks prior to study (stratum 3)
* Concurrent valproic acid allowed if combined with another enzyme inducing anticonvulsant drug (stratum 3)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
21 Years
Study:
NCT00016861
Study Brief:
Protocol Section:
NCT00016861